scholarly journals Estimating the effects of accelerated partner therapy (APT) on reinfection of index cases with chlamydia: a mathematical modelling study

2021 ◽  
Author(s):  
Christian L. Althaus ◽  
Claudia L. Estcourt ◽  
Nicola Low
Keyword(s):  
Mathematical Model ◽  
Randomised Controlled Trial ◽  
Chlamydia Trachomatis ◽  
Controlled Trial ◽  
Control Period ◽  
Partner Notification ◽  
Credible Interval ◽  
Intervention Period ◽  
Randomised Controlled ◽  
Index Cases

Objectives The expected effects of accelerated partner therapy (APT) on the reinfection of treated index cases by untreated partners with Chlamydia trachomatis (chlamydia) remain unclear. We analyzed data from the LUSTRUM cluster cross-over randomised controlled trial (RCT) using a mathematical model and quantified the effects of offering APT on the probability of successful partner treatment. Methods We extended a previously developed mathematical model to compute the probability of chlamydia reinfection of index cases by their untreated partners with chlamydia. We fitted the model to data from the RCT and estimated the probability of successful treatment of the partner of index cases using a Bayesian framework. Results We estimated the median probability of reinfection with chlamydia at 16.3% (50% credible interval, CrI: 12.7-20.0%) without partner treatment and 2.3% (50% CrI: 1.7-3.6%) when partner treatment is 100% successful. The observed rates of reinfection in the RCT were 6.7% (95% confidence interval, CI: 5.6-8.0%) during the control period (standard partner notification (PN)) and 4.8% (95% CI: 3.7-5.9%) during the intervention period where APT was offered in addition to standard PN. These rates correspond to a median probability of successful partner treatment of 63% (50% CrI: 47-76%) during the control period and 78% (50% CrI: 65-87%) during the intervention period. Conclusions Our study suggests that the observed reduction in reinfection with chlamydia when offering APT is consistent with a higher probability of successful partner treatment.

scholarly journals Optimal protamine dosing after cardiopulmonary bypass: The PRODOSE adaptive randomised controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (6) ◽  
pp. e1003658
Author(s):  
Lachlan F. Miles ◽  
Christiana Burt ◽  
Joseph Arrowsmith ◽  
Mikel A. McKie ◽  
Sofia S. Villar ◽  
...  
Keyword(s):  
Mathematical Model ◽  
Cardiopulmonary Bypass ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Fixed Ratio ◽  
Red Blood Cell Transfusion ◽  
Pleural Drainage ◽  
Model Group ◽  
Randomised Controlled ◽  
Protamine Administration

Background The dose of protamine required following cardiopulmonary bypass (CPB) is often determined by the dose of heparin required pre-CPB, expressed as a fixed ratio. Dosing based on mathematical models of heparin clearance is postulated to improve protamine dosing precision and coagulation. We hypothesised that protamine dosing based on a 2-compartment model would improve thromboelastography (TEG) parameters and reduce the dose of protamine administered, relative to a fixed ratio. Methods and findings We undertook a 2-stage, adaptive randomised controlled trial, allocating 228 participants to receive protamine dosed according to a mathematical model of heparin clearance or a fixed ratio of 1 mg of protamine for every 100 IU of heparin required to establish anticoagulation pre-CPB. A planned, blinded interim analysis was undertaken after the recruitment of 50% of the study cohort. Following this, the randomisation ratio was adapted from 1:1 to 1:1.33 to increase recruitment to the superior arm while maintaining study power. At the conclusion of trial recruitment, we had randomised 121 patients to the intervention arm and 107 patients to the control arm. The primary endpoint was kaolin TEG r-time measured 3 minutes after protamine administration at the end of CPB. Secondary endpoints included ratio of kaolin TEG r-time pre-CPB to the same metric following protamine administration, requirement for allogeneic red cell transfusion, intercostal catheter drainage at 4 hours postoperatively, and the requirement for reoperation due to bleeding. The trial was listed on a clinical trial registry (ClinicalTrials.gov Identifier: NCT03532594). Participants were recruited between April 2018 and August 2019. Those in the intervention/model group had a shorter mean kaolin r-time (6.58 [SD 2.50] vs. 8.08 [SD 3.98] minutes; p = 0.0016) post-CPB. The post-protamine thromboelastogram of the model group was closer to pre-CPB parameters (median pre-CPB to post-protamine kaolin r-time ratio 0.96 [IQR 0.78–1.14] vs. 0.75 [IQR 0.57–0.99]; p < 0.001). We found no evidence of a difference in median mediastinal/pleural drainage at 4 hours postoperatively (140 [IQR 75–245] vs. 135 [IQR 94–222] mL; p = 0.85) or requirement (as a binary outcome) for packed red blood cell transfusion at 24 hours postoperatively (19 [15.8%] vs. 14 [13.1%] p = 0.69). Those in the model group had a lower median protamine dose (180 [IQR 160–210] vs. 280 [IQR 250–300] mg; p < 0.001). Important limitations of this study include an unblinded design and lack of generalisability to certain populations deliberately excluded from the study (specifically children, patients with a total body weight >120 kg, and patients requiring therapeutic hypothermia to <28°C). Conclusions Using a mathematical model to guide protamine dosing in patients following CPB improved TEG r-time and reduced the dose administered relative to a fixed ratio. No differences were detected in postoperative mediastinal/pleural drainage or red blood cell transfusion requirement in our cohort of low-risk patients. Trial registration ClinicalTrials.gov Unique identifier NCT03532594.

Intensified partner notification and repeat testing can improve the effectiveness of screening in reducing Chlamydia trachomatis prevalence: a mathematical modelling study

2021 ◽  
pp. sextrans-2021-055220
Author(s):  
Ben B Hui ◽  
Jane S Hocking ◽  
Sabine Braat ◽  
Basil Donovan ◽  
Christopher K Fairley ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Controlled Trial ◽  
Partner Notification ◽  
Population Level ◽  
Cluster Randomised Controlled Trial ◽  
Base Case ◽  
Relative Reduction ◽  
Treatment Rate ◽  
Chlamydia Testing ◽  
Randomised Controlled

BackgroundThe Australian Chlamydia Control Effectiveness Pilot (ACCEPt) was a cluster randomised controlled trial designed to assess the effectiveness of annual chlamydia testing through general practice in Australia. The trial showed that testing rates increased among sexually active men and women aged 16–29 years, but after 3 years the estimated chlamydia prevalence did not differ between intervention and control communities. We developed a mathematical model to estimate the potential longer-term impact of chlamydia testing on prevalence in the general population.MethodsWe developed an individual-based model to simulate the transmission of Chlamydia trachomatis in a heterosexual population, calibrated to ACCEPt data. A proportion of the modelled population were tested for chlamydia and treated annually at coverage achieved in the control and intervention arms of ACCEPt. We estimated the reduction in chlamydia prevalence achieved by increasing retesting and by treating the partners of infected individuals up to 9 years after introduction of the intervention.ResultsIncreasing the testing coverage in the general Australian heterosexual population to the level achieved in the ACCEPt intervention arm resulted in reduction in the population-level prevalence of chlamydia from 4.6% to 2.7% in those aged 16–29 years old after 10 years (a relative reduction of 41%). The prevalence reduces to 2.2% if the proportion retested within 4 months of treatment is doubled from the rate achieved in the ACCEPt intervention arm (a relative reduction of 52%), and to 1.9% if the partner treatment rate is increased from 30%, as assumed in the base case, to 50% (a relative reduction of 59%).ConclusionA reduction in C. trachomatis prevalence could be achieved if the level of testing as observed in the ACCEPt intervention arm can be maintained at a population level. More substantial reductions can be achieved with intensified case management comprising retesting of those treated and treatment of partners of infected individuals.

scholarly journals Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ulrich Reininghaus ◽  
Annelie Klippel ◽  
Henrietta Steinhart ◽  
Thomas Vaessen ◽  
Martine van Nierop ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Daily Life ◽  
Controlled Trial ◽  
Psychotic Experiences ◽  
Intervention Period ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

Abstract Background Psychotic experiences, social functioning and general psychopathology are important targets for early intervention in individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP). Acceptance and Commitment Therapy (ACT) is a promising, next-generation Cognitive Behavioural Therapy (CBT) that aims to modify these targets, but evidence on sustainable change and its underlying mechanisms in individuals’ daily lives remains limited. The aim of the INTERACT study is to investigate the efficacy of a novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL) in a multi-centre randomised controlled trial of individuals with UHR or FEP. Methods/design In a multi-centre randomised controlled trial, individuals aged 16–65 years with UHR or FEP will be randomly allocated to ACT-DL in addition to treatment as usual (TAU) as the experimental condition or a control condition of TAU only, which will include – for the entire study period – access to routine mental health care and, where applicable, CBT for psychosis (CBTp). Outcomes will be assessed at baseline (i.e. before randomisation), post-intervention (i.e. after the 8-week intervention period), and 6-month and 12-month follow-ups (i.e. 6 and 12 months after completing the intervention period) by blinded assessors. The primary outcome will be distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology. Process measures to assess putative mechanisms of change will include psychological flexibility, stress sensitivity and reward experiences. In addition, acceptability, treatment adherence and treatment fidelity of ACT-DL will be assessed. Discussion The current study is the first to test the efficacy of ACT-DL in individuals with UHR and FEP. If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services. Trial registration Netherlands Trial Register, ID: NTR4252. Registered on 26 September 2013.

scholarly journals Partner notification of chlamydia infection in primary care: randomised controlled trial and analysis of resource use

BMJ ◽  
2005 ◽  
Vol 332 (7532) ◽  
pp. 14-19 ◽  
Author(s):  
Nicola Low ◽  
Anne McCarthy ◽  
Tracy E Roberts ◽  
Mia Huengsberg ◽  
Emma Sanford ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Resource Use ◽  
Controlled Trial ◽  
Partner Notification ◽  
Chlamydia Infection ◽  
Randomised Controlled

scholarly journals Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037303
Author(s):  
Fumiya Tanji ◽  
Yasutake Tomata ◽  
Saho Abe ◽  
Sanae Matsuyama ◽  
Yumika Kotaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Intervention Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

scholarly journals Impact of decreasing the proportion of higher energy foods and reducing portion sizes on food purchased in worksite cafeterias: A stepped-wedge randomised controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (9) ◽  
pp. e1003743
Author(s):  
James P. Reynolds ◽  
Minna Ventsel ◽  
Daina Kosīte ◽  
Brier Rigby Dames ◽  
Laura Brocklebank ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Energy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Portion Size ◽  
Stepped Wedge ◽  
Intervention Period ◽  
Portion Sizes ◽  
Energy Products ◽  
Randomised Controlled

Background Overconsumption of energy from food is a major contributor to the high rates of overweight and obesity in many populations. There is growing evidence that interventions that target the food environment may be effective at reducing energy intake. The current study aimed to estimate the effect of decreasing the proportion of higher energy (kcal) foods, with and without reducing portion size, on energy purchased in worksite cafeterias. Methods and findings This stepped-wedge randomised controlled trial (RCT) evaluated 2 interventions: (i) availability: replacing higher energy products with lower energy products; and (ii) size: reducing the portion size of higher energy products. A total of 19 cafeterias were randomised to the order in which they introduced the 2 interventions. Availability was implemented first and maintained. Size was added to the availability intervention. Intervention categories included main meals, sides, cold drinks, snacks, and desserts. The study setting was worksite cafeterias located in distribution centres for a major United Kingdom supermarket and lasted for 25 weeks (May to November 2019). These cafeterias were used by 20,327 employees, mainly (96%) in manual occupations. The primary outcome was total energy (kcal) purchased from intervention categories per day. The secondary outcomes were energy (kcal) purchased from nonintervention categories per day, total energy purchased per day, and revenue. Regression models showed an overall reduction in energy purchased from intervention categories of −4.8% (95% CI −7.0% to −2.7%), p < 0.001 during the availability intervention period and a reduction of −11.5% (95% CI −13.7% to −9.3%), p < 0.001 during the availability plus size intervention period, relative to the baseline. There was a reduction in energy purchased of −6.6% (95% CI −7.9% to −5.4%), p < 0.001 during the availability plus size period, relative to availability alone. Study limitations include using energy purchased as the primary outcome (and not energy consumed) and the availability only of transaction-level sales data per site (and not individual-level data). Conclusions Decreasing the proportion of higher energy foods in cafeterias reduced the energy purchased. Decreasing portion sizes reduced this further. These interventions, particularly in combination, may be effective as part of broader strategies to reduce overconsumption of energy from food in out-of-home settings. Trial registration ISRCTN registry ISRCTN87225572.

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